Penumbra is initiating a voluntary Field Removal of the original version of its Neuron 6F 070 Delivery Catheter, the U.S. Food and Drug Administration (FDA) just announced. Penumbra has received feedback from some users that these recalled catheters could kink or ovalize in certain anatomical situations.

This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued use of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury, or death. To date, there have been four injury reports, which may be potentially associated with this defect. (more…)

A report from the Food & Drug Administration (FDA) says the agency caved to political pressure when it approved ReGen Biologics Inc.’s Menaflex knee device. According to The Wall Street Journal, the FDA is now reconsidering its approval of Menaflex.

Menaflex is meant to repair a torn meniscus, which basically acts as a shock absorber for the knee. Menaflex was approved through a process known as 510(K), which doesn’t require human clinical trials, and is meant for devices that are substantially similar to products already on the market. (more…)

The U.S. Food and Drug Administration (FDA) just announced it commissioned the Institute of Medicine (IOM) to study the pre-market notification program used to review and clear certain medical devices marketed in the United States.

The study will examine the program, also called the 510(k) process, for medical devices, which can be accessed here. The 510(k) process was established under the Medical Device Amendments of 1976 to ensure safe and effective devices are made available to consumers and to promote innovation in the medical device industry. (more…)

U.S. Health Regulators warned today that Philips Lifeline Personal Help Buttons can pose a choking hazard. According to a notice posted on the Food & Drug Administration (FDA) website, there have been at least six reports between 1998 and 2009 of serious injury or death, including three deaths in the United States and one in Canada, from choking after the cord on the Philips Lifeline Personal Help Button became entangled on other objects worn around the neck.

According to Philips Lifeline, the device is used primarily by seniors living independently, who feel they are at risk for falls or other medical emergencies. By pushing the “help” button on the device when in distress, users can call for emergency assistance to their home. (more…)

Senator Charles Grassley (R-Iowa) has expanded his investigation of Dr. David Polly. As we’ve reported previously, the relationship between Dr. Polly, head of spine surgery at the University of Minnesota, and Medtronic Inc. has been under scrutiny.

Grassley’s probe of Dr. Polly has already revealed that he had been paid $1.2 million by Medtronic between 2003 and 2007 for consulting work. Dr. Polly had come under fire in July for not disclosing his relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries. According to Minneapolis-St. Paul Business Journal, Dr. Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance. (more…)

A prominent cardiologist with ties to Columbia University is facing questions regarding his ties to medical devices makers, the New York Times is reporting. According to the Times report, two U.S. Senators are concerned that Dr. Martin B. Leon may not have reported all payments he received from companies like Boston Scientific, Johnson & Johnson, Medtronic and the Volcano Corporation to Columbia.

According to the Times, Sens. Charles Grassley (R-Iowa) and Sen. Herbert Kohl (D-Wisc.) have been investigating Dr. Leon’s financial relationship with the medical device industry since last year. Last October, they sent letters to the Cardiovascular Research Foundation (CRF) and Columbia University regarding Dr. Leon and several other physicians. According to the Times, CRF sponsors an annual conference – the Transcatheter Cardiovascular conference – that has highlighted products developed by companies in which Dr. Leon and other CRF-affiliated doctors have financial stakes. (more…)

Physio-Control, Inc., a division of Medtronic, Inc., is recalling LifePak CR Plus Automated External Defibrillators (AED). The Food & Drug Administration (FDA) has deemed this a Class I recall.

This recalled device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.

According to the recall notice, an extremely humid environment may cause the LifePak CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

The recalled LifePak CR Plus AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008. Devices with the following serial numbers are affected by this recall:

37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211,37038365, 37135986, 37154526, 37154638

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

The Evenflo Co. did not properly investigate reports that its “Comfort Select” breast pumps caused some women to suffer electric shocks. In a warning letter dated August 25, the Food & Drug Administration (FDA) also said that during inspections earlier this year, several manufacturing violations were found at two Ohio plants that make the pumps.

According to the warning letter, the FDA said Evenflo received thirty-seven complaints involving breast pumps, but did not investigate 18 of them. Three complaints highlighted by the letter involved electric shocks. The FDA noted that Evenflo’s response to this and several other violations had been “adequate.”

An Evenflo official told The Wall Street Journal that the company does investigate its consumer complaints but said the problem was a “documentation issue.”

Another violation noted in the letter included the failure to verify or validate corrective and preventive actions to ensure that such actions were effective and would not adversely affect the finished device. The letter says that Evenflo’s response to this finding was only “partially adequate” because corrective actions did not extend to the Comfort Select pumps it sold prior to December 2008.

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The FDA also says the company still needs to develop medical device reporting procedures for its breast pumps that identify, evaluate and report complaints that might be subject to federal reporting requirements.

Evenflo had 15 working days from the date of the warning letter to notify the FDA of the specific steps the company has taken to correct the noted violations. Failure to do so could result in regulatory action being initiated by the FDA against Evenflo. Such actions include, but are not limited to, seizure, injunction, and/or civil money penalties.

Medtronic Inc. is recalling Sutureless Connector (SC) intrathecal catheters. In letters

sent to physicians, Medtronic said that that the current SC catheter labeling incorrectly states that SC catheters are compatible with the IsoMed infusion pump.

mirrormask divx download According to a Medtronic press release, the Food & Drug Administration (FDA) has deemed this a Class I recall. Class I recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

A physical interference between the SC catheter connector and the IsoMed pump prevents the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure. This incompatibility is design related and is not a result of implant technique. This incompatibility may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.

The clinical manifestations of an incomplete connection of an SC catheter to an IsoMed pump may include, but are not limited to, drug or cerebrospinal fluid (CSF) leakage into surrounding tissue, resulting in tissue damage, loss of or change in therapy, a return of underlying symptoms, drug withdrawal symptoms, a severe (”spinal”) headache, and/or a clinically significant or fatal drug underdose. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. The IsoMed pump is not FDA approved in the United States for the administration of baclofen.

To date, Medtronic has received 10 reports related to improper connection of these catheters to an IsoMed pump. In all of these incidents, medical intervention was required to correct the condition. According to the Medtronic press release, one of these patient died two days following a surgery to fix the catheter’s faulty connection to the pump, However, the company said it cannot be determined whether the cause of death is or is not related to the device.

Products affected by this recall include the following models: SC Catheter and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the IsoMed Pump Model 8472, which is no longer manufactured and marketed. Medtronic stopped producing IsoMed infusion pumps in September 2008 as part of a planned product phase-out. Other types of intrathecal catheters and intravascular catheters for delivery of chemotherapy are not affected by this issue.

Confidential documents obtained by the Star Tribune and originally cited by Australia’s Sydney Morning Herald, point to medical device maker, Medtronic Inc. closing the ring dvdrip download , being caught in a “secret marketing strategy.”

The strategy allegedly involved courting doctors in exchange for fellowship grants in 2007, said the Star Tribune, broadening the controversy about Medtronic’s payment practices not only in the United States, but, now, in Australia, as well. It seems, reported the Star Tribune that, based on documents it obtained, “$1.5 million spent on 18 fellowship grants” would provide “a 200 percent return on investment in the first year.” The Tribune quoted the documents as stating that the aim of the strategy was to “build a community of practitioners that embrace Medtronic’s mission,” and “secure … new business revenue streams.”

The overarching concern with such relationships in which finances are exchanged between Industry and researchers is that a bias exists that excludes patient welfare. For instance, in this case, according to the Tribune, a brochure about a Medtronic-sponsored event about spine care took place at a tony venue in Australia’s wine country. It seems the event occurred last month, despite the negative coverage pointing to the growing trend in reports of physicians and researchers receiving large industry payments.

One of the speakers listed at the resort meeting was a prominent former military physician who also consulted for Medtronic until this summer after being accused by the U.S. Army of falsifying a study involving a Medtronic spine product, said the Tribune. Ultimately, the physician, Dr. Timothy Kuklo, did not speak at the meeting. Another controversial doctor, whose relationship with Medtronic has received some attention from Senator Charles Grassley (Republican-Iowa), was scheduled to speak. Dr. David Polly, the head of spine surgery at the University of Minnesota’s Medical School, is—based on an email he wrote—still a Medtronic consultant, said the Tribune.

Grassley, a ranking member of the Senate Finance Committee investigating medical device firms and doctor relationships has long been looking into the alleged negligence surrounding reporting practices. Those concerned say the conflicts can affect critical decisions about research and subsequent treatments, according to a prior Wall Street Journal piece. Because of Grassley’s investigations, restrictions have been put in place that limit the money researchers accept from Industry, publicize funds received, and restrict consultant and speaker roles, said the Journal. A number of states also mandate medical companies to report payments made to in-state doctors, and a bill has been sponsored by Grassley and others, requiring national disclosure, said the Journal.

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A Medtronic spokeswoman said Medtronic’s Australasia management learned of the marketing program in mid-2007, calling it “inappropriate” and not in keeping with conduct standards; the program was terminated, reported the Tribune.